External fixation assembly and method of use

ABSTRACT

An external fixation assembly includes a plurality of hollow pins that are inserted into a patient&#39;s bone. Each pin has an interior bore and a plurality of apertures extending through the pin wall from the bore. The pin may be coupled to a source of vacuum pressure operable to create reduced pressure in the tissue surrounding the pin. A cover is placed around the pin and sealed to provide a fluid-tight enclosure that maintains reduced pressure around the pin. A method for applying external fixation using the fixator pins described above includes the steps of inserting each pin through a skin opening, positioning the pin apertures near selected tissue, covering the skin opening with a sealed enclosure, connecting the pins to a source of vacuum pressure, and activating the source of vacuum pressure to create reduced pressure in the patient&#39;s tissue at or near the bone.

RELATED APPLICATIONS

This application claims the benefit of priority of U.S. ProvisionalApplication No. 60/866,327, filed on Nov. 17, 2006, the entire contentsof which application are incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to external fixation, and particularly tofixator pins and devices used in treating bone fractures and deformitieswith the use of sub-atmospheric pressure.

BACKGROUND

External fixation is a common technique used to treat a variety ofconditions, including bone fractures, dislocations, and deformities.Although different techniques are used, external fixation generallyinvolves the use of threaded fixator pins that are screwed into bone.For bone fractures, two or more fixator pins are inserted into the boneon each side of the fracture. Compression and distraction forces areapplied to the fixator pins to correctly position and align the bone.External fixation may be applied over several months for complicatedfractures, during which time the pin remains in the bone. Long term useof external fixator pins involves risks and complications that can delaythe patient's recovery and further aggravate the patient's condition. Insome patients, the pin may result in infection within the pin tract inthe bone. In addition, the skin around the pin/skin interface can becomeirritated or infected. The pin may also become unstable and loosened inthe bone. Therefore, there is a need for improved implements and devicesthat reduce the risks and complications associated with externalfixation.

SUMMARY OF THE INVENTION

Based on the foregoing, an external fixation assembly includes aplurality of hollow fixator pins for insertion into a patient's bone.Each pin has a hollow shaft with an insertion end that may be advancedthrough a tissue opening and into the patient's bone. The shaft has aninterior passageway or conduit such as a bore that extends generallyalong the longitudinal axis of the shaft. At least one vent aperture,and optionally a plurality of vent apertures, extend through the shaftin fluid communication with the bore. The pin may be removably connectedto a source of vacuum pressure operable to draw fluid or gas through theaperture of the pin and apply reduced pressure in the tissue surroundingthe pin. The reduced pressure may be used to stimulate blood circulationaround the tissue opening, reduce the potential for inflammation andinfection, and stabilize the fixator pin in the bone.

The shaft may include a first inner section or insertion end, such as athreaded section, for securing the fixator pin in the bone. In addition,the shaft may include a second outer section, such as a non-threadedsection. A connection port is provided on the shaft, for example, alongor at an end of the outer section to fluidly connect to or communicatewith the bore inside the pin. The port may be connected to the source ofvacuum pressure by a suitable connection such as a flexible tube. Acover is removably disposed around the pin and surrounds the tissueopening to form a generally fluid-tight enclosure that is sufficient toenable sub-atmospheric pressure, i.e., negative pressure, to bemaintained beneath the cover. A pressure distribution element, such as aporous screen, may additionally be placed at or around the pin andbetween the tissue opening and the cover to permit sub-atmosphericpressure to be distributed beneath the cover and at the tissue openingand, optionally, to substantially prevent direct contact between thetissue opening and the cover.

If a plurality of vent apertures are utilized, the apertures may belocated on one or more sections of the shaft to apply reduced pressureto different selected locations along the shaft and optionally todifferent tissue areas. For example, the apertures may be formed in theouter or non-threaded section of the shaft and adapted to apply reducedpressure at the epidermis or external to the epidermis. In addition, theapertures may be formed in the inner or threaded section and adapted toapply a reduced pressure in the pin tract in the bone. Alternatively,the apertures may be formed in two separate areas on the non-threadedsection of the shaft to apply reduced pressure for example, to one ormore of a sub-cutaneous layer or organ, the epidermis and/or a tissuelayer in the dermis. As yet a further alternative, apertures may beprovided in the inner or threaded section as well as the outer ornon-threaded section, as well as along different areas of the outersection, to supply reduced pressure at any one or all of the bone,sub-cutaneous tissue or organs, the dermis, the epidermis, and to areasbeneath the cover and outside of the epidermis, or any other selectedtissues or organs enclosed and sealed within the cover.

A method for applying external fixation using the hollow fixator pinsdescribed above includes the step of inserting each pin through a skinopening and into bone. The pin is positioned so that the apertures arein substantial alignment with selected tissue. For example, theapertures could be aligned with the epidermis, or positioned inside thepin tract in the bone or at other desired locations. Once the pins areplaced, the skin opening around each pin is covered with a sealedenclosure. The hollow pins are connected to a source of vacuum pressure.The source of vacuum pressure functions to create reduced pressure thatis supplied from the pin apertures in the patient's bone tissue or anysoft tissues outside of the bone as desired.

DESCRIPTION OF THE DRAWINGS

The foregoing summary as well as the following description will bebetter understood when read in conjunction with the Figures in which:

FIG. 1 is a schematic view of an external fixation assembly inaccordance with the present invention.

FIG. 2A is a cross-sectional view of components used in accordance withthe present invention, featuring a first embodiment of a fixator pin.

FIG. 2B is a cross-sectional view of components used in accordance withthe present invention, featuring an implantable pin portion.

FIG. 3 is a cross-sectional view of components used in accordance withthe present invention, featuring a second embodiment of a fixator pin.

FIG. 4 is an enlarged cross-sectional view of a threaded section of thefixator pin of FIG. 3, broken away at one end for clarity.

FIG. 5 is a cross-sectional view of components used in accordance withthe present invention, featuring a third embodiment of a fixator pin.

FIG. 6 is a cross-sectional view of components used in accordance withthe present invention, featuring a fourth embodiment of a fixator pin.

FIGS. 7A and 7B are cross-sectional view of components used inaccordance with the present invention, featuring a fourth embodiment ofa fixator pin.

FIG. 8 is a cross-sectional view of components used in accordance withthe present invention, featuring a guide pin used in conjunction with afixator pin.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to the drawing figures in general, and to FIG. 1specifically, an external fixator assembly 10 is shown in accordancewith the invention. In general, the fixator assembly may include fourhollow fixator pins 20 inserted into bone tissue 4 in the patient onopposite sides of a fracture or other deformity 8 so that suitablecompression or distraction forces can be applied. Each fixator pin 20 ispositioned at a pin site and connected to a source of vacuum pressure12. Negative or reduced pressure, e.g., sub-atmospheric pressure, isapplied at each pin site to stimulate blood circulation to the pin site,to reduce the potential for inflammation and infection, and to stabilizethe fixator pin. While each of the fixator pins 20 shown in FIG. 1 is acannulated pin for supplying reduced pressure, other fixatorarrangements could be utilized in which one or more fixation pins arecannulated while one or more other pins are not cannulated. Thenon-cannulated pins may be used at pin sites where the application ofreduced pressure is contra-indicated or is not desired or needed.

Each cannulated fixator pin 20 has a hollow shaft and sidewall 23 thatforms an internal bore 25. The fixator pin 20 may be cannulated from anouter end 24 to provide an access port 28 at the outer port end thatleads to the internal bore that extends from the outer end 24 to theinner or tip end 27 of the pin. To preserve the integrity of the tip,the bore 25 may terminate before extending through the tip end. Thefixator pin 20 is removably connected to the source of vacuum pressure12 by suitable connectors or tubing 14, such as flexible tubes,removably coupled to the port end 24 of the pin 20. One or more ventapertures 34 extend through the sidewall 23 of the fixator pin 20 andcommunicate with the bore in the shaft. The source of vacuum pressure 12is operable to draw fluid or gas through the apertures 34 and bore 25 tocreate negative pressure at the interface between the pin and tissuearound the pin.

Referring now to FIGS. 1-2, the external fixator assembly 10 will bedescribed in more detail. For purposes of clarity, the fixator assembly10 is shown in simplified form with a fixator device 18 having twofixator pins 20 on each side of a bone fracture or other deformity 8. Itwill be appreciated that more than two fixator pins 20 may be insertedon each side of the bone fracture 8, depending on the location andnature of the fracture. In addition, it will be appreciated that thefixator assembly 10 is not strictly intended for bone fractures, and maybe applied to other conditions, including for example, dislocations anddeformities. The assembly 10 may incorporate a variety of fixatordevices, and the specific type of fixator is not critical. For example,the fixator assembly 10 may be used with flexible or rigid fixators. Inaddition, the fixator assembly 10 may be applied to different fracturetypes and fracture locations, including for example, femural fracturesand tibial fractures.

The fixator 18 includes a pair of retainers 21, with each retainerpositioned on one side of the bone fracture 8. One or more bars connectbetween the retainers 21 and are operable to apply compression anddistraction forces on the fixator pins. In FIG. 1, the retainers 21 areconnected, for example, by a compression bar 19A and a distraction bar19B.

Referring now to FIG. 2A, a fixator pin 20 is shown having a hollow orcannulated shaft 23 with an attachment end 24 (the port end) and aninsertion end 26 (the tip end). The bore 25 extends through the hollowshaft 23 of the cannulated fixator pin 20 and provides fluidcommunication from the attachment end 24 to the insertion end 26. Avacuum port 28 is formed at or through the attachment end 24 of theshaft 23 and is in fluid communication with the bore 25. The attachmentend 24 is adapted to receive an end of flexible tubing 14 in a sealed,snug fit as the tube slides over the attachment end 24 to provide afluid flow path to the vacuum port 28, as shown in FIG. 1. The flexibletubing 14 has an interior lumen with a diameter substantially equal tothe outer diameter of the fixator pin 20. As such, the flexible tubing14 is configured to slide over the attachment end 24 of the fixator pin20 and form a substantially fluid-tight seal. The flexible tube 14connects the fixator pin 20 with a source of vacuum pressure 12. Avariety of vacuum pressure sources may be used with the fixator assembly10, including, for example a Gast Vacuum pump (Fischer Scientific).

The pin 20 has a first threaded section 30 that may taper to form asharp point or tip 27, and a second non-threaded section 33. The pin 20may have other configurations wherein the tip end does not taper to apoint or does not taper at all. The threaded section 30 is configured topenetrate into the bone 4 to securely anchor the fixator pin 20 into thepin tract in the bone 4. For this purpose, the pin may include aself-tapping threaded tip 27 for tapping into bone 4. Alternatively, thefixator pin may be provided in the from of a transfixing pin 420, 520for positioning through a limb, FIGS. 7A and 7B. In such a use, the pin420 may have a threaded middle portion 430 with smooth end portions orthe entire pin 520 may be threaded 530, and the pin 420, 520 may beprovided with a Trocar tip. Vent apertures 435, 535 may be provided inthe middle portion of the pin 420, 520 or may be provided peripherally,e.g., vent apertures 434, 534.

As shown schematically in FIG. 2A, the pin 20 screws into the bone 4 tohold the pin firmly in place. For this purpose, the pin 20 may bescrewed into the bone a desired depth greater than that specificallydepicted in FIG. 2A so that the non-tapered portion 33 extends into thebone to anchor the pin in place. Optionally, a portion of the pin 20,such as tip 27, may be detachable to provide an implant that may be leftin the patient, as shown in FIG. 2B. In such a configuration the pin 20,or the implant portion, e.g. tip 27, may comprise a bone substitutematerial. For example, the pin 20 or tip 27 may comprise a natural,synthetic, or natural-synthetic hybrid porous material, and may comprisea material to support or direct osteoconduction or a material to inducedifferentiation of stem cells to osteogenic cells, i.e. osteoinductiveagents, or materials which provide stem cells, e.g. bone marrowaspirate.

For example, the pin 20 or tip 27 may be a bioglass, ceramic material,or other natural or synthetic porous material, such as calcium sulphateor calcium phosphate. One suitable calcium sulphate bone substitute isOSTEOSET® Bone Graft Substitute, a product of Wright Medical Technology,Inc. of Arlington Tenn. Another class of suitable materials is onecomprising various derivates of calcium phosphate, which can be used toprovide a structural matrix for osteoconduction, such as hydroxyapatite(coral based or chemically derived synthetic ceramic), fluorapatite,tri-calcium phosphate, bioglass ceramics and combinations thereof. Onesuitable calcium phosphate bone substitute is OsteoGraft™ Bone GraftSubstitute, a product of Millenium Biologix of Kingston, Ontario,Canada. In addition, the pin 20 or tip 27 need not comprise a bonesubstitute material and may comprise a metal or other suitablematerials.

In addition, a guide pin 636 may be used in conjunction with theopen-ended fixator pin 424 to aid in guiding placement of the fixatorpin 424, FIG. 8. For instance, a narrow guide pin 636 having across-sectional dimension less than that of the bore 425 may be placedin the bone 4 prior to placement of the fixator pin 424, allowing thephysician to first verify that the guide pin 636 has been placed in thecorrect location. The location of the guide pin 636 may be determined byan x-ray or other suitable imaging modality. After the guide pinlocation has been verified, the fixator pin 424 may be inserted in thebone 4 by placing the fixator pin 424 over the guide pin 636 so that theguide pin 636 is located within the bore 425 of the fixator pin.

Returning now to FIG. 2A, a plurality of apertures 34 may be formedthrough the non-threaded section 33 of the shaft 23 to form a ventsection 35 along the length of the shaft. The apertures 34 extendthrough the wall of the shaft 23. When the vacuum pump 12 is activated,the vacuum pump draws air or gas through the apertures 34 to createnegative pressure through and along the apertures. The apertures 34 maybe positioned at various locations relative to the tip 27 to applyreduced pressure at specific areas within the pin tract. For example,the apertures 34 may be positioned where the pin intersects with theepidermis 5 (“skin/pin interface”), as shown in FIG. 2. In thisarrangement, the apertures may form a vent section 35 at a location atand above the epidermis to supply negative pressure through areduced-pressure distribution element or screen 50. Alternatively, theapertures 34 may be positioned where the pin intersects deeper tissuelayers in the dermis 6. Apertures may be concentrated at one section ofthe shaft 23 to treat a specific tissue layer, or may be formed atmultiple sections of the shaft to supply reduced pressure to multiplelayers or tissues. In FIG. 6, a second embodiment of a fixator pin 320is shown with apertures 334 positioned at one section of the shaft tosupply reduced pressure at the skin/pin interface and apertures 335positioned at another section of the shaft to supply reduced pressure atdeeper tissue layers in the dermis 6. As shown in FIG. 3, the tip end ofthe fixator pin 120 may also include apertures 134 to supply reducedpressure to bone 4 at the pin/bone interface. The pins 20, 120, 220,320, 420, 520 may also be used intermittently or continuously to effectdelivery of medication, such as antibiotics, local anesthetic, andbiopharmaceuticals, to the various tissue/pin interfaces by introducingmedication into the bore for delivery through the vent apertures.

A fluid-tight enclosure or cover 60, such as OpSite or TEGADERM, ispositioned over the pin 20 to cover the pin site. The cover 60 isconfigured to form a fluid-tight seal around the pin site to maintainthe reduced pressure that is applied at the tissue/pin interface. Thecover 60 includes an inner face that faces into the pin site, and anouter face that faces outwardly and away from the pin site when thecover is placed over the pin 20. The inner face may include an adhesivebacking 61 that adheres to the patient's skin around the periphery 63 ofthe pin site. Alternatively, or in addition, other adhesives or sealersmay be applied. The adhesive backing has sufficient adhesive propertiesto form a fluid-tight enclosure around the periphery of the pin site andto hold the cover 60 in sealed contact with the patient's skin whenreduced pressure is applied beneath the cover. The cover may beimpermeable or semipermeable depending on the level of permeabilityneeded or desired for a particular application as long as the desiredlevel of reduced pressure is maintained beneath the cover for a desiredamount of time to effect the desired treatment.

A hole or opening 37 is formed through a central or interior portion ofthe cover 60 and is adapted to fit over the attachment end 24 of thefixator pin 20 as the attachment end 24 of the pin is inserted throughthe hole 37. The cover 60 engages the outer circumference of the pin ina fluid tight seal to substantially prevent leakage of pressure throughthe hole around the pin. Optionally, the cover 60 may incorporate anO-ring seal 64 at the hole 37 in the cover that is adapted to squeezearound and seal onto the outer periphery of the pin. The O-ring 64engages the exterior of the fixator pin 20 when the cover is placed overthe pin. The O-ring 64 has an inner diameter substantially equal to theouter diameter of the fixator pin 20 and is configured to frictionallyengage the outer surface of the pin. The O-ring 64 may be affixed to thecover 60 around the hole 37 by an adhesive or other bonding.Alternatively, the O-ring may be embedded within the cover or heatsealed into the cover. For example, the cover 60 may include two pliesthat form a pocket in which the O-ring 64 is embedded. The frictionalengagement between the O-ring 64 and pin 20 forms a fluid-tight sealbetween the exterior of the pin and the cover.

It may be desirable to stabilize the O-ring axially on the pin 20.Referring to FIG. 2A, the pin 20 includes a pair of circumferentialridges 36 on the outer section of the pin that form a seat for theO-ring 64. The ridges 36 form a narrow groove having a thickness anddiameter suitable to seat the O-ring 64. The groove is adapted toreceive the O-ring when the cover is placed over the pin 20. As aresult, the seat formed by the ridges 36 limits the axial displacementof the O-ring 64 and cover 60 along the length of the pin 20. The O-ringmay be formed of any flexible elastomeric material that permits theO-ring to be stretched. In this way, the O-ring 64 can be stretched totemporarily expand the inside diameter of the O-ring to allow it to beslipped over the top ridge and into the seat allowing the O-ring toslide into and become properly seated within the seat groove.

A reduced-pressure distribution element such as a porous screen 50 maysurround the apertures 34 on the fixator pin 20 as shown in FIG. 2A. Thescreen 50 is positioned beneath the cover 60 and over the pin site tohelp distribute reduced pressure across its surface area and tooptionally help keep the cover out of direct contact with the skinaround the pin 20. The screen 50 has sufficient porosity to permit theflow of gases into the apertures of the pin when reduced pressure isapplied by the vacuum pump. The screen 50 may also absorb exudate andother liquids that may aspirate from the tissue around the pin site.Preferably, the screen 50 is formed out of an open cell polymer foam,such as polyurethane foam. Other porous or perforated materials may alsobe used. Foams may be used with a wide range of pore sizes anddensities. Since the fixator assembly 10 usually rests on top of thepatient's extremity, it may be desirable to select a light-weight lowdensity foam or sponge that is less noticeable to the patient. It mayoptionally be desirable to form large perforations or other flow pathsin the screen 50 to reduce the weight of the screen or to increase theflow of gas drawn by the vacuum pump. In FIG. 2A, the screen 50 andcover 60 are cut to fit over a single pin site. Other screen and coverconfigurations may be used, however, and the configurations illustratedin the drawing figures are not intended to be the only workableconfigurations. For example, it may be desirable to use a single screen50 and cover 60 over multiple pin sites. This may be desirable wherepins are spaced close together in a relatively small area.

The fixator assembly 10 may be used in the following manner. After thepin locations are selected, small incisions are made through the skin atthe pin locations, and the fixator pins 20 are placed into the patient'sbone. The desired pin location may include a fracture or a joint to beimmobilized. In such a case where the pin 20 is inserted in the fractureor joint, the pin 20 may desirably include an implantable portion whichmay optionally comprises a bone substitute material. The pins 20 areadvanced into the bone until the pin apertures are positioned at adesired axial locations relative to the tissue/pin interface. Forexample, as shown in FIG. 2A, the apertures 34 may be positioned at theskin/pin interface in substantial alignment at, with or above theepidermis 5 or in communication with the screen 50. Alternatively, asshown in FIG. 6, the apertures 335 may also be positioned adjacent totissue in the dermis 6 either exclusively or in conjunction withapertures at another location such apertures 334 at or above theepidermis 5. Apertures may be provided at other locations as well.Screens 50 are secured over the pins around the apertures and over theincisions. Covers 60 are then placed over the pins 20, and the adhesivesurfaces on the inner faces of the covers are pressed firmly against thepatient's skin to form a fluid tight enclosure around the pin sites.Many types of suitable covers may be used. The fixator 18 is thenassembled and connected with the fixator pins. Once the fixator 18 isassembled, flexible tubes 14 are connected to the attachment ends of thefixator pins 20 and to the suction port of the vacuum pump 12.

The vacuum pump 12 is activated to apply reduced pressure within thespace 70 beneath the cover 60 as shown in FIG. 2A. The amount ofpressure reduction applied at the pin sites is dependent on the desiredcourse of treatment, the location of the pins, the density of the screenmaterial, and other variables. For example, the reduced pressure may bebetween 10 mm Hg below atmospheric pressure and 300 mm Hg belowatmospheric pressure. In the embodiment shown in FIG. 3, reducedpressure is supplied to the pin/bone interface at apertures 134 whilethe cover and optional screen help to maintain the negative pressure atthat site.

Thus far, the fixator pins have been described primarily with aperturesthat are positioned to apply reduced pressure at the epidermis and/ordermis. It will be appreciated that reduced pressure may be applied atdeeper levels in the pin incision and need not be limited to the dermisor epidermis. For example, reduced pressure may be applied, as shown inFIG. 3, at the interface between the fixator pin and bone (“bone/pininterface”) by apertures 134 positioned at the bone 4 of FIG. 3.Application of reduced pressure in bone tissue is intended to reduce theoccurrence of pin tract infection and inflammation in the bone. Inaddition, the application of reduced pressure in bone tissue is intendedto increase bone growth and bone ingrowth in the pin tract, whichincreases stability of the pin.

Referring now more specifically to FIG. 3, a third embodiment of afixator pin 120 is shown. The fixator pin 120 is configured to applyreduced pressure at the bone/pin interface in a pin tract. The fixatorpin 120 is substantially similar to the pins described above, having ahollow shaft 131 with a central bore 125, an insertion end 126, athreaded section 130 on the insertion end, a non-threaded section 133,and a plurality of apertures 134. The apertures 134 are formed in thethreaded section 130 of the insertion end 126 as opposed to thenon-threaded section 133 of the shaft. In this way, the reduced pressureis applied through bore 125 to the pin tract inside the bone 4.Referring to FIG. 4, the apertures 134 are preferably recessed in thegroove formed by the thread on the threaded section at the tip 137. Thegroove provides additional void space around the apertures to reduce thepotential for clogging caused by bone fragments that may become lodgedin the apertures.

In some cases, it may be desirable to locate the vacuum port as a sideport on the side of the pin, rather than at the attachment end. Forexample, the fixator appliance may have retainers that connect over thetop of the fixator pins, covering the attachment ends of the pins andpreventing connection of flexible tubing to the attachment ends.Therefore, locating the vacuum port on the side of the pin can avoidproblems that occur when the attachment end is obstructed orinaccessible. In FIG. 5, a fourth embodiment of a fixator pin 220 isshown in accordance with the invention. The fixator pin 220 is connectedto a retainer 221 that covers the end of the fixator pin. A vacuum port228 is formed through the side wall of the pin 220 and connects with aflexible tube 214. A cylindrical hub 229 surrounds the vacuum port 228and projects radially outwardly from the side wall of the pin 220. Theflexible tube 214 is adapted to slide over the hub 229 to connect theport 228 to a vacuum pump or other source of reduced pressure. The hub229 has an outer diameter that is substantially equal to the innerdiameter of the flexible tube 214. In this way, the flexible tube slidesover the hub in frictional engagement to form a fluid-tight seal aroundthe port 228.

The terms and expressions which have been employed are used as terms ofdescription and not of limitation. There is no intention in the use ofsuch terms and expressions of excluding any equivalents of the featuresshown and described or portions thereof. It is recognized, therefore,that various modifications are possible within the scope and spirit ofthe invention. Accordingly, the invention incorporates variations thatfall within the scope of the following claims.

1. A method for applying external fixation to a bone defect comprisingthe steps of: A. inserting a fixator pin through a skin opening and intobone, the pin comprising i. a hollow shaft having an insertion end forinsertion into the bone and an attachment end for positioning externallyto the bone for communication with a vacuum source, said shaft forming abore that extends along a longitudinal axis of the shaft and having aport in communication with the bore; ii. a threaded section of the shaftfor securing the pin in the bone; and iii. a plurality of apertures thatextend through a wall of the shaft in fluid communication with the bore,said apertures located proximate a region of the attachment end andexternal to the insertion end to provide a plurality of apertures forcommunication with a location external to the bone; B. connecting thepin to a fixator device; C. positioning a porous reduced-pressuredistribution element around the pin, said porous reduced-pressuredistribution element adapted to distribute negative pressure; D.covering the skin opening and the porous reduced-pressure distributionelement with a removable cover to create a sealed enclosure around thepin, the cover disposed at a location relative to the apertures of thepin such that the enclosure communicates with the apertures to providenegative pressure to the enclosure through the apertures; E. connectinga vacuum source with the hollow shaft of the pin via a flexible tuberemovably connectable with the port on the pin to supply negativepressure to the pin; and F. activating the vacuum source to apply areduced pressure to the sealed enclosure through the pin apertures. 2.The method of claim 1, wherein the plurality apertures are formedproximate a region of both the insertion end and attachment end toprovide apertures for communication with regions internal and externalto the bone.
 3. The method of claim 1, wherein the port extends throughthe attachment end of the shaft.
 4. The method of claim 1, wherein theport is formed through a sidewall of the shaft.
 5. The method of claim4, wherein the port comprises a cylindrical hub that extends radiallyoutwardly from the shaft.
 6. The method of claim 1, wherein the covercomprises an O-ring seal and the shaft comprises a pair ofcircumferential ridges separated by a groove adapted to form a seat toreceive the O-ring seal.
 7. The method of claim 1, wherein thereduced-pressure distribution element comprises an open cell foam. 8.The method of claim 1, comprising a detachable shaft section to providean implant that may be left in the bone.
 9. The method of claim 8,wherein the detachable shaft section comprises a bone substitutematerial.
 10. The method of claim 9, wherein the detachable shaftsection comprises an osteoconductive material, an osteoinductivematerial, or combinations thereof.
 11. The method of claim 9, whereinthe detachable shaft section comprises a bioglass, a ceramic material,calcium sulphate, calcium phosphate, hydroxyapatite, fluorapatite,tri-calcium phosphate, bioglass ceramics, or combinations thereof. 12.The method of claim 1, wherein the pin comprises a bone substitutematerial.
 13. The method of claim 12, wherein the pin comprises anosteoconductive material, an osteoinductive material, or combinationsthereof.
 14. The method of claim 12, wherein the pin comprises abioglass, a ceramic material, calcium sulphate, calcium phosphate,hydroxyapatite, fluorapatite, tri-calcium phosphate, bioglass ceramics,or combinations thereof.
 15. The method of claim 1, comprising a guidepin for insertion into the bone, and wherein the bore of the fixationpin is dimensioned to permit the guide pin to be inserted therein. 16.The method of claim 1, wherein the step of inserting the pin comprisesplacing the apertures adjacent to epidermis.
 17. The method of claim 1,wherein the step of inserting the pin comprises placing the apertureswithin dermis.
 18. The method of claim 1, wherein the step of insertingthe pin comprises positioning at least one of the apertures in the bone.19. The method of claim 1, wherein the reduced pressure is applied topromote bone formation at the bone defect.
 20. The method of claim 19,wherein the step of positioning the porous reduced pressure distributionelement comprises placing the porous reduced pressure distributionelement between the skin opening and the cover.
 21. The method of claim19, comprising introducing a medication to the hollow shaft anddelivering the medication through the apertures to the selected tissue.22. The method of claim 15, comprising inserting a guide pin into thebone and wherein the step of inserting the hollow fixator pin comprisesplacing the fixator pin over the guide pin so that at least a portion ofthe guide pin is disposed within the hollow shaft of the fixator pin.